Events

Retiro De Equipo (Recall) de Device Recall Thermedx Fluid Management System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Thermedx LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68986
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2555-2014
  • Fecha de inicio del evento
    2014-02-10
  • Fecha de publicación del evento
    2014-08-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129203
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Vacuum powered body fluid collection Kit - Product Code OJR
  • Causa
    A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. the deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.
  • Acción
    Thermedx sent an Urgent Product Correction letter dated March 15, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were notified that the devices were in need of correction, and that it would be performed at their facilities by Thermedx. Customers with questions were instructed to call a Thermedx technical service representative at 1-888-542-9276. For questions regarding this recall call 440-542-0883.

Device

Device Recall Thermedx Fluid Management System
  • Modelo / Serial
    Model P4000 Serial numbers affected:  20110004, 20110007, 20110015, 20110025, 20130001-20130032, 20140001-20140005
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including HI, MS, NY, OH, PA, VA, WA, WV, and IL.
  • Descripción del producto
    The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant.
  • Manufacturer
    Thermedx LLC

Manufacturer

Thermedx LLC
  • Dirección del fabricante
    Thermedx LLC, 31200 Solon Rd, Unit 1, Solon OH 44139-3556
  • Empresa matriz del fabricante (2017)
    Thermedx LLC
  • Source
    USFDA